A Washington man recently filed a lawsuit claiming that he was permanently injured after receiving a medical device designed to treat aneurysms. The device, marketed as the Penumbra Coil 400, was designed to be placed inside a blood vessel in the brain in order to help repair aneurysms and prevent them from getting worse. In 2011, the Food and Drug Administration (FDA) issued a recall on this device, but it was again cleared for use in 2012. The plaintiff’s lawyer has noted that it’s not clear if the device used on the victim was from a recalled lot or if newer devices still have a problem.
The Penumbra Coil 400 is a small coil of special wire meant to strengthen the blood vessel around an aneurysm in order to prevent further damage and allow the body to accelerate its own healing process. Some studies have found the device to be safe and effective, but even these note potential complications. When the 2011 recall was announced, it was not specifically for the coil itself but rather the accompanying microcatheter delivery system used to implant it. This system had a defect that allowed the coil to be released before it was fully in place. This incorrect placement could lead to serious injury, including blood clots and stroke. That’s exactly what the attorney for Dennis Montgomery claims happened to his client, even though Mr. Montgomery received the device more than a year after it was again declared safe.
The 2011 action was a Class I recall, the highest type the FDA issues. This indicates “a reasonable probability” that the device “will cause serious adverse health consequences or death.” The manufacturer had stated at the time that all affected devices had been accounted for and returned.
Mr. Montgomery received a Penumbra Coil 400 in 2013. His suit claims that the device could only be inserted 90 percent of the way into the aneurysm, and that because the delivery system did not work properly and the device detached prematurely, the doctor performing the operation was unable to remove and reposition it. The coil—and the stents used during the operation—had to be left in Montgomery’s brain. This led to blood clots, which in turn caused a stroke. He is now unable to work and has been in pain ever since.
Although few serious problems have been reported with the Penumbra Coil 400 device so far, a similar product of the same class was also recalled because of the risk a manufacturing defect presented to some patients. In 2014, the Pipeline Embolization Device for aneurysm treatment and its accompanying Alligator Retrieval Device were both recalled by their manufacturer, Covidien, and the FDA. The wires used to deliver the devices were coated with a layer of Teflon that, due to a change in the manufacturing process in some lots, could separate during or after use. As with the Penumbra Coil, this had the potential to lead to blood clots, which in turn could lead to stroke. Fortunately, there were no reports of patients actually being harmed before the device was recalled.
Medical devices are supposed to be proven safe before they reach the public. When this doesn’t happen, which seems to be the case in this instance, a patient can be seriously harmed or even killed. The risk might be due to a quality control issue or a manufacturing defect, but sometimes the hazard is known to those selling the device. Whether the risk is the result of an accident or negligence, any victim is entitled to seek restitution when harm results.
The law firm of Craig Swapp & Associates has experience with legal actions involving liability for defective products. If you or a loved one has been harmed by a defective product, such as a dangerous medical device, it’s important to recruit a legal team that can help in your pursuit of justice. Give us a call today at 800-404-9000 for a free consultation to go over the details of your case. You can also contact us with our online form or have many of your questions answered in minutes by opening the LiveChat application from any page of our website.